RedHill initiates recruitment for expanded Phase 2 opaganib/darolutamide study

RedHill Biopharma (RDHL) announced the initiation of patient recruitment into the Phase 2 study evaluating the efficacy of opaganib in combination with darolutamide4 in men with metastatic castrate-resistant prostate cancer, sponsored by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group in Australia, and supported by Bayer (BAYRY) and Ramsay Hospital Research Foundation. The Company also announced the study will recruit people across at least 10 sites across Australia and New Zealand.Led by Professor Lisa Horvath, from Sydney’s Chris O’Brien Lifehouse, and ANZUP, the innovative 60-participant placebo-controlled randomized study is designed to test the potentially enhancing effect of opaganib in overcoming resistance to standard of care androgen receptor pathway inhibition treatment. The unique study will utilize a companion lipid biomarker test to select mCRPC patients who have poor prognosis to standard of care treatment, and who may benefit from an opaganib + darolutamide combination approach to treatment. The study’s primary endpoint is improved 12-month radiographic progression-free survival. Several secondary and exploratory endpoints will also be evaluated.